# K961784: Copalis One Immunoassay System/Toxoplasma Gondii/Rubella/CMV Total Antibody Assays

- Pathway: 510(k) (Traditional)
- Applicant: Sienna Biotech, Inc.
- Decided: Oct 31, 1996 after 182 days
- Product code: LQN (Latex Agglutination Assay, Rubella)
- Device class: 2
- Regulation: 21 CFR 866.3510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BioWhittaker Toxostat: named in the summary without a submission number
- (no number) Becton Dickinson And Co. Rubascan: named in the summary without a submission number
- (no number) Becton Dickinson And Co. CMVscan: named in the summary without a submission number
- (no number) Abbott IMx: named in the summary without a submission number

## Indications for use
The Copalis™ TORC, Toxo, Rubella, and CMV Total Antibody Assays use Coupled Particle Light Scattering (Copalis) technology in microparticle agglutination-based immunoassays for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and/or cytomegalovirus (CMV) in human serum using the Copalis™ | Inmunoassay System. The presence of antibodies is indicative of current or prior infection with the suspected organism. The results of these assays on a single serum specimen are used to determine the patient’s immune status for rubella and to determine the patient’s immunological experience for Toxoplasma gondii and CMV. When evaluating properly paired sera, the results of these assays are used to demonstrate seroconversion as evidence of recent infection. Both specimens should be tested simultaneously (see Interpretation of Results). These assays has not been FDA cleared or approved for the screening of blood or plasma donors. The assay will also be offered as separate microparticle immunoassays for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and cytomegalovirus (CMV) in human serum using the Copalis™ One Immunoassay System. The intended use of the individual assays will be specific to the individual antibodies detected but, other than that, will remain the same as the combination assay.

Source page: https://510kreport.com/device/K961784
Methodology: https://510kreport.com/methodology